Prolonged-release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients

Summary

Phase 4, single center, double-blind, placebo-controlled study. Fifty (50) patients with MacDonald criteria (2005) multiple sclerosis will undergo active motor training as per the NeuroGym protocol, consisting of 3 sessions of 1 hour per week for a period of 6 weeks (total of 18 sessions). Half of the patients will be randomized to receive prolonged-release fampridine 10 mg BID as per label, and the other half will receive a placebo BID. All patients will continue to take their medication (fampridine or placebo) during a subsequent observational period of 8 weeks. Patients will be evaluated at times -4, 0, 6 and 14 weeks. Study Objectives: Primary: To demonstrate that MS subjects treated with prolonged-release fampridine 10mg BID will show greater benefit from active motor training as compared with subjects treated with placebo in terms of incidence of responders, degree of response, and duration of response. Secondary: To demonstrate that MS subjects treated with prolonged-release fampridine 10mg BID will show greater benefit from active motor training as compared with subjects treated with placebo in terms of quality of life measures.

Timeline

Start

2013-12

Primary completion

2016-01

Completion

2016-01

Publications

• Jacques F, Schembri A, Nativ A, Paquette C, Kalinowski P. Prolonged-Release Fampridine as Adjunct Therapy to Active Motor Training in MS Patients: A Pilot, Double-Blind, Randomized, Placebo-Controlled Study. Mult Scler J Exp Transl Clin. 2018 Mar 9;4(1):2055217318761168. doi: 10.1177/2055217318761168. eCollection 2018 Jan-Mar.

Drugs

Indications